A polyunsaturated fatty acid is defined as a fatty acid including two or more carbon-carbon double bonds in one molecule, and the polyunsaturated fatty acids are categorized by the position of the double bond into ω3 fatty acid, ω6 fatty acid, and the like. The ω3 polyunsaturated fatty acids include α-linolenic acid, icosapentaenoic acid (EPA), and docosahexaenoic acid (DHA), and the ω6 polyunsaturated fatty acids include linoleic acid, γ-linolenic acid, and arachidonic acid. Polyunsaturated fatty acids exhibit various actions including antiarteriosclerotic action, platelet aggregation inhibitory action, hypolipidemic action, antiinflammatory action, antitumor action, and central action, and therefore, polyunsaturated fatty acids are incorporated in various foods, or sold as a health food or pharmaceutical product. For example, ethyl icosapentaenoate (EPA-E) which is a polyunsaturated fatty acid is commercially available as a therapeutic agent for arteriosclerosis obliterans (ASO) and hyperlipidemia.
Since polyunsaturated fatty acid is susceptible to oxidation, and peculiar smell develops with the oxidation, the polyunsaturated fatty acid is generally incorporated in a capsule to thereby prevent the oxidation and seal the unpleasant smell. In the meanwhile, several hundred milligrams to several grams of polyunsaturated fatty acid should be taken at one dose to achieve the effect as described above, and this results in the problems of difficulty of taking a large capsule, difficulty of taking many capsules at a time, and the like. Such problems are particularly serious in the case of elderly patients with reduced ability of swallowing. Taking such large-size capsule and/or large-number capsules has also been highly unpleasant in the case of patients who are allowed to take only limited amount of water because they had to take the large-size capsule and/or large-number capsules with the limited amount of water. In addition, a dosage form which can be conveniently used in the administration to the so called “bedridden” patients requiring tube administration has also been demanded.
The patients who are taking the EPA-E for the hyperlipidemia often suffer from complication with other diseases, and in such a case, they are required to take two or more drugs, and a typical such case is metabolic syndrome. In the case of metabolic syndrome, patients suffer from complication of two or more of hypertension, abnormal glucose tolerance, dyslipidemia, obesity, and the like, and such multiplicity of the risk factors resulted in the higher occurrence of coronary artery diseases, cerebral infarction, and the like. Recently, this attracted public attention. In the U.S., the number of patients suffering from the metabolic syndrome is estimated to be as high as 50,000,000, and this has become a social problem. Increase in the number of patients is also feared in Japan where Westernization of the life has occurred. Treatment of the metabolic syndrome is based on the improvement of lifestyle, and more specifically, on the alimentary therapy and kinesitherapy. However, such improvement of the dietary life or the lack of exercise is often difficult in the patients suffering from the “lifestyle-related diseases”, and they usually transfer to pharmacotherapy in order to prevent poor prognosis, for example, onset of myocardial infarction or cerebral infarction. As described above, metabolic syndrome simultaneously involves hypertension, abnormal glucose tolerance, and dyslipidemia, and therefore, the treatment would be based on the administration of a plurality of drugs, and the patients have to take a plurality of drugs for a long period. However, taking multiple drugs for a long period precisely as prescribed without any error or forgetting is difficult, and this is particularly true since patients of the metabolic syndrome are often elderly people including the people suffering from reduced swallowing ability. For such group of patients, dosage forms of conventional preparations such as tablet, capsule, powder, and granules have not always been easy to take.
Such patients with reduced swallowing ability often develop pneumonia from aspiration of food or beverage into the trachea. Such aspiration is known to occur less frequently in the case of a highly viscous gel or a jelly compared to liquid with low viscosity such as water (see Fujishima, I. “Eating from mouse: Q&A on dysphagia” published from Chuohoki Publishers Co., Ltd.). In view of such situation, jelly preparations have recently been developed as pharmaceutical preparations which can be easily taken by patients with low swallowing ability. Exemplary such commercially available jelly preparations include Acivir Oral Jelly (manufactured by Teikoku Medix Co., Ltd. and sold by Nikken Chemical) having acyclovir (an antiviral drug) incorporated therein, Ciloslet Oral Jelly (manufactured by Teikoku Medix Co., Ltd. and sold by Zeria Pharmaceutical Co., Ltd.) having cilostazol (a therapeutic agent for chronic artery obstruction) incorporated therein, and Pabron Cough Medicine <Stick Jelly> (manufactured by Teikoku Medix Co., Ltd. and sold by Taisho Pharmaceutical Co., Ltd.) which is an over-the-counter drug.
Jelly preparations are known in the art, and examples include the jelly composition having incorporated therein carageenan, locust bean gum, xanthan gum, and phosphate buffer solution together with Chinese medicine bulk (see, for example, Patent Document 1), and a jelly composition having incorporated therein carageenan, carob bean gum, poly(sodium acrylate), and a surfactant together with cilostazol (antiplatelet drug) (see, for example, Patent Document 2). However, a jelly composition containing a polyunsaturated fatty acid and a second pharmaceutical component is neither disclosed nor suggested in such known jelly compositions having a pharmaceutical component incorporated therein.
A drug containing a transmucosal absorbefacient comprising a polyunsaturated fatty acid and a polymer gel is also disclosed (see, for example, Patent Document 3). In this document, however, the polyunsaturated fatty acid and the macromolecule gel are used as an aid (transmucosal absorbefacient) for facilitating absorption of a substance that is not readily absorbed from the digestive tract (for example, insulin) from the mucosa, for example, by rectal administration, and the pharmaceutical and pharmacological action of the polyunsaturated fatty acid itself is neither disclosed nor suggested.
As a preparation containing a second pharmaceutical component together with the polyunsaturated fatty acid, a tablet containing DHA with simvastatin and vitamins has been disclosed (see for example, Patent Document 4). Also disclosed is a method for incorporating a liquid active component in a solid pharmaceutical composition (see for example, Patent Document 5). This document discloses a sachet having a mixture of ω3 triglyceride and simvastatin filled therein.
However, none of these prior art documents disclosing the combination of the polyunsaturated fatty acid and a second pharmaceutical component teach or suggest the jelly composition.    [Patent Document 1] JP 2001-114696 A    [Patent Document 2] JP 2005-82536 A    [Patent Document 3] JP 2000-128805 A    [Patent Document 4] JP 2004-514684 A    [Patent Document 5] JP 2005-508982 A